Clinical Trials in India are regulated under the Central Drugs Standard Control Organization (CDSCO) and Drugs and Cosmetics Act, 1940, respectively. Rule 122 DAA of Drugs & Cosmetics Rules, 1945 (“D & C Rules”) defines clinical trials as a “systematic study of new drug(s) in human subject(s) to generate data for discovering and/or verifying the clinical, pharmacological (including pharmacodynamics and pharmacokinetic) and/or adverse effects with the objective of determining safety and / or efficacy of the new drug”.
The clinical research market in India is presently valued at a figure of USD 500 million and is projected to reach USD 1 billion by 2016. This market is driven by the availability of a huge genetically diverse population with extremely lower costs when compared to the developed nations. However, the regulatory delays in the clinical trials are harming the prospects of clinical trials in India. The delays and regulatory ambiguity have wrecked innovation as well as growth of the clinical trial industry. After the amendment in January 2013, ineffective regulatory oversight, need for protection for informed consent of vulnerable populations and compensation guidelines for patients for trial related deaths have materialized as chief concerns.
Recently, Biocon has been compelled to move various Indian projects to the US and Europe. The situation only makes the process more cumbersome but also results in a 10-20 times hike in the cost of drug development. In the past two years, companies like Piramal Enterprises and Lupin were also forced to go abroad for conducting clinical trials, due to slow and uncertain approval processes in India with the matter being challenged in court.
If India has to ...
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...low when compared to that of the acute therapies but its growth has outperformed the market. With the right support from the government and friendly policies the sector is expected to see a good growth in the near future.
The small and medium enterprises (SMEs) are expected to play a significant role in the growth story of the country's pharma sector as they contribute 35–40 per cent to the industry in terms of production with a turnover of about Rs.35,000 crore (US$ 5.70 billion).
But we have also seen sluggish growth in the recent quarter and that can be attributed to some of the policy changes. To ensure that the sector keeps growing at a healthy rate Indian and foreign companies in the sector have to come up with certain innovative strategies like:
• Venturing into newer markets
• Use of new and improved technology
• Portfolio expansion
• Portfolio Optimization
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